Pacing catheter for access to multiple vessels

ABSTRACT

Cardioprotective pacing is applied to prevent and/or reduce cardiac injury associated with myocardial infarction (MI) and revascularization procedure. Pacing pulses are generated from a pacemaker and delivered through a plurality of pacing leads introduced into a patient&#39;s body through a percutaneous transluminal vascular intervention (PTVI) catheter have a plurality of exit ports. In one embodiment, the exit ports are arranged for the pacing leads to enter multiple specified blood vessels.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/074,035, filed on Jun. 19, 2008, under 35 U.S.C. §119(e), which ishereby incorporated by reference.

This application is related to co-pending, commonly assigned, U.S.patent application Ser. No. 11/113,828, entitled “METHOD AND APPARATUSFOR PACING DURING REVASCULARIZATION”, filed on Apr. 25, 2005, U.S.patent application Ser. No. 11/468,875, entitled “INTEGRATED CATHETERAND PULSE GENERATOR SYSTEMS AND METHODS”, filed on Aug. 31, 2006, U.S.Patent Application Ser. No. 61/074,032, entitled “PACING CATHETER WITHEXPANDABLE DISTAL END”, filed on Jun. 19, 2008, U.S. Patent ApplicationSer. No. 61/074,042, entitled “PACING CATHETER RELEASING CONDUCTIVELIQUID”, filed on Jun. 19, 2008, U.S. Patent Application Ser. No.61/074,048, entitled “PACEMAKER INTEGRATED WITH VASCULAR INTERVENTIONCATHETER”, filed on Jun. 19, 2008, U.S. Patent Application Ser. No.61/074,055, entitled “TRANSVASCULAR BALLOON CATHETER WITH PACINGELECTRODES ON SHAFT”, filed on Jun. 19, 2008, U.S. Patent ApplicationSer. No. 61/074,060, entitled “PACING CATHETER WITH STENT ELECTRODE”,filed on Jun. 19, 2008, U.S. Patent Application Ser. No. 61/074,064,entitled “VASCULAR INTERVENTION CATHETERS WITH PACING ELECTRODES”, filedon June 19, U.S. Patent Application Ser. No. 61/074,066, entitled“EXTERNAL PACEMAKER WITH AUTOMATIC CARDIOPROTECTIVE PACING PROTOCOL”,filed on even date herewith, U.S. Patent Application Ser. No.61/074,024, entitled “METHOD AND DEVICE FOR PACING AND INTERMITTENTISCHEMIA”, filed on Jun. 19, 2008, which are hereby incorporated byreference in their entirety.

TECHNICAL FIELD

This document relates generally to cardiac pacing systems andparticularly to a system for delivering cardioprotective pacing duringrevascularization procedure.

BACKGROUND

The heart is the center of a person's circulatory system. It includes anelectro-mechanical system performing two major pumping functions. Theleft portions of the heart draw oxygenated blood from the lungs and pumpit to the organs of the body to provide the organs with their metabolicneeds for oxygen. The right portions of the heart draw deoxygenatedblood from the body organs and pump it to the lungs where the blood getsoxygenated. These pumping functions are resulted from contractions ofthe myocardium (cardiac muscles). In a normal heart, the sinoatrialnode, the heart's natural pacemaker, generates electrical impulses,called action potentials, that propagate through an electricalconduction system to various regions of the heart to excite themyocardial tissues of these regions. Coordinated delays in thepropagations of the action potentials in a normal electrical conductionsystem cause the various portions of the heart to contract in synchronyto result in efficient pumping functions. A blocked or otherwiseabnormal electrical conduction and/or deteriorated myocardial tissuecause dyssynchronous contraction of the heart, resulting in poorhemodynamic performance, including a diminished blood supply to theheart and the rest of the body. The condition in which the heart failsto pump enough blood to meet the body's metabolic needs is known asheart failure.

Myocardial infarction (MI) is the necrosis of portions of the myocardialtissue resulted from cardiac ischemia, a condition in which themyocardium is deprived of adequate oxygen supply and metabolite removaldue to an interruption in blood supply caused by an occlusion of a bloodvessel such as a coronary artery. The necrotic tissue, known asinfarcted tissue, loses the contractile properties of the normal,healthy myocardial tissue. Consequently, the overall contractility ofthe myocardium is weakened, resulting in an impaired hemodynamicperformance. Following an MI, cardiac remodeling starts with expansionof the region of infarcted tissue and progresses to a chronic, globalexpansion in the size and change in the shape of the entire leftventricle. The consequences include a further impaired hemodynamicperformance and a significantly increased risk of developing heartfailure.

When a blood vessel such as the coronary artery is partially orcompletely occluded, a revascularization procedure such as percutaneoustransluminal coronary angioplasty (PTCA) can be performed to reopen theoccluded blood vessel. However, the revascularization procedure itselfinvolves a temporary occlusion of the coronary artery. Reperfusion thatfollows the reopening of the occluded blood vessel is also known tocause cardiac injury, known as reperfusion injury. In addition, plaquesdislodged and displaced by the revascularization procedure may entersmall blood vessels branching from the blood vessel in which therevascularization is performed, causing occlusion of these small bloodvessels. The revascularization procedure may also cause distalembolization, i.e., obstruction of the artery caused by the plaquedislodged during the procedure. Therefore, there is a need forminimizing cardiac injury associated with MI and the subsequentrevascularization procedure.

SUMMARY

Cardioprotective pacing is applied to prevent and/or reduce cardiacinjury associated with myocardial infarction (MI) and revascularizationprocedure. Pacing pulses are generated from a pacemaker and deliveredthrough one or more pacing electrodes incorporated onto one or morepercutaneous transluminal vascular intervention (PTVI) devices duringthe revascularization procedure. The pacemaker controls the delivery ofthe pacing pulses by automatically executing a cardioprotective pacingprotocol.

In one embodiment, cardioprotective pacing is delivered duringrevascularization of a blood vessel. A PTVI device assembly includes aplurality of pacing leads and a catheter. The pacing leads each includea distal end portion and one or more pacing electrodes incorporated ontothe distal end portion. The catheter includes one or more entry portsand a plurality of exit ports and allows the distal end portion of eachpacing lead of the plurality of pacing leads to enter an entry port ofthe one or more entry ports and exit from an exit port of the pluralityof exit ports.

In one embodiment, a system delivers cardioprotective pacing to twoblood vessels during a revascularization procedure. The system includestwo pacing leads and a catheter. The two pacing leads each include adistal end portion with a pacing electrode. The catheter accommodates aportion of each of the two pacing leads and allows the distal endportion of each of the two pacing leads to exit from the catheter andenter a blood vessel.

In one embodiment, a method for delivering cardioprotective pacingduring revascularization is provided. A PTVI device assembly isprovided. The PTVI device assembly includes a catheter and a pluralityof pacing leads. The catheter includes one or more entry ports and aplurality of exit ports. The pacing leads each include a distal endportion introduced into one of the blood vessels by entering an entryport of the one or more entry ports and exiting from an exit port of theplurality of exit ports. The distal end portion of each pacing leadincludes one or more pacing electrodes. Pacing pulses are deliveredthrough the plurality of pacing leads.

This Summary is an overview of some of the teachings of the presentapplication and not intended to be an exclusive or exhaustive treatmentof the present subject matter. Further details about the present subjectmatter are found in the detailed description and appended claims. Otheraspects of the invention will be apparent to persons skilled in the artupon reading and understanding the following detailed description andviewing the drawings that form a part thereof. The scope of the presentinvention is defined by the appended claims and their legal equivalents.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate generally, by way of example, variousembodiments discussed in the present document. The drawings are forillustrative purposes only and may not be to scale.

FIG. 1 is an illustration of an embodiment of a system providing forpacing during revascularization and portions of an environment in whichthe system is used.

FIG. 2 is a block diagram illustrating an embodiment of a pacemakerproviding for pacing during revascularization.

FIG. 3 is a timing diagram illustrating an embodiment of acardioprotective pacing protocol.

FIG. 4 is an illustration of an embodiment of a guide catheter withpacing electrodes.

FIG. 5 is an illustration of an embodiment of a guide wire with pacingelectrodes.

FIG. 6 is an illustration of an embodiment of an angioplasty catheterwith pacing electrodes.

FIG. 7 is an illustration of an embodiment of a distal portion of theguide catheter with pacing electrodes.

FIG. 8 is an illustration of another embodiment of a distal portion ofthe guide catheter with pacing electrodes.

FIG. 9 is an illustration of another embodiment of a distal portion ofthe guide catheter with pacing electrodes.

FIG. 10 is an illustration of an embodiment of a distal portion of theguide wire with pacing electrodes.

FIG. 11 is an illustration of another embodiment of a distal portion ofthe guide wire with pacing electrodes.

FIG. 12 is an illustration of an embodiment of a distal portion of theangioplasty catheter with a balloon and pacing electrodes.

FIG. 13 is an illustration of an embodiment of a proximal portion of theangioplasty catheter with pacing electrodes.

FIG. 14 is an illustration of an embodiment of a pacing catheterincluding a sheath and a pacing lead having an expandable distal end.

FIG. 15 is an illustration of an embodiment of the distal end portion ofa pacing lead of the pacing catheter of FIG. 14.

FIG. 16 is an illustration of another embodiment of the distal endportion of a pacing lead of the pacing catheter of FIG. 14.

FIG. 17 is an illustration of another embodiment of the distal endportion of a pacing lead of the pacing catheter of FIG. 14.

FIG. 18 is an illustration of an embodiment of a percutaneoustransluminal vascular intervention (PTVI) device assembly including apacing lead and a balloon catheter.

FIG. 19 is an illustration of an embodiment of a pacing catheterincluding multiple pacing leads for access to multiple blood vessels.

FIG. 20 is an illustration of an embodiment of a catheter of the pacingcatheter of FIG. 19.

FIG. 21 is an illustration of an embodiment of a pacing catheterreleasing conductive liquid and an injection device.

FIG. 22 is an illustration of another embodiment of a pacing catheterreleasing conductive liquid.

FIGS. 23A-B are an illustration of another embodiment of a pacingcatheter releasing conductive liquid.

FIG. 24 is an illustration of an embodiment of a pacemaker integratedinto a PTVI device.

FIG. 25 is an illustration of an embodiment of the pacemaker of FIG. 24.

FIG. 26 is an illustration of another embodiment of a pacemakerintegrated into a PTVI device.

FIG. 27 is an illustration of another embodiment of a pacemakerintegrated into a PTVI device.

FIG. 28 is an illustration of another embodiment of a pacemakerintegrated into a PTVI device.

FIG. 29 is an illustration of an embodiment of an angioplasty catheterincluding pacing electrodes on the shaft.

FIG. 30 is an illustration of an embodiment of a sleeve of theangioplasty catheter of FIG. 29.

FIG. 31 is an illustration of another embodiment of an angioplastycatheter including pacing electrodes on the shaft.

FIG. 32 is an illustration of another embodiment of an angioplastycatheter including pacing electrodes on the shaft.

FIG. 33 is an illustration of another embodiment of an angioplastycatheter including pacing electrodes on the shaft.

FIG. 34 is an illustration of an embodiment of a pacing catheterassembly including a stent catheter with a stent electrode.

FIG. 35 is an illustration of an embodiment of the distal end portion ofthe stent catheter of FIG. 34.

FIG. 36 is an illustration of another embodiment of the distal endportion of the stent catheter of FIG. 34.

FIG. 37 is an illustration of another embodiment of the distal endportion of the stent catheter of FIG. 34.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that the embodiments may be combined, or that otherembodiments may be utilized and that structural, logical and electricalchanges may be made without departing from the spirit and scope of thepresent invention. The following detailed description provides examples,and the scope of the present invention is defined by the appended claimsand their legal equivalents.

It should be noted that references to “an”, “one”, or “various”embodiments in this disclosure are not necessarily to the sameembodiment, and such references contemplate more than one embodiment.

In this document, “revascularization” includes reopening of a completelyor partially occluded blood vessel using percutaneous transluminalvascular intervention (PTVI) procedure, such as a percutaneoustransluminal coronary angioplasty (PTCA) procedure performed in responseto cardiac ischemia or myocardial infarction (MI), using PTVI devicessuch as those discussed in this document.

This document discusses a pacing system that delivers pacing pulsesthrough one or more PTVI devices to a patient receiving arevascularization procedure. In an application, the pacing systemprovides for acute pacing cardioprotection therapy, also referred to aspacing postconditioning, during the revascularization procedure. Theacute pacing cardioprotection therapy includes the delivery of pacingpulses before, during, and/or after the temporary occlusion of acoronary artery to prevent and/or reduce cardiac injury associated withMI and the subsequent revascularization procedure. The pacing system iscapable of delivering the acute pacing cardioprotection therapy withoutsubstantially interfering with the revascularization procedure. Inanother application, the pacing system also provides for ischemiccardioprotection therapy. The ischemic cardioprotection therapy includesintermittent occlusion of the coronary artery, for example, byperiodically inflating and deflating a balloon of a PTVI device.

To deliver pacing pulses during the revascularization procedure, one ormore pacing electrodes are incorporated onto the one or more PTVIdevices. Examples of such PTVI devices include guide wires, guidecatheters, and angioplasty catheters such as dilatation ballooncatheters, stent delivery systems, brachytherapy devices, atherectomydevices, and distal embolization protection devices. A pacemakerconnected to the one or more PTVI devices generates the pacing pulses.In one embodiment, the pacemaker controls the delivery of the acutepacing cardioprotection therapy by automatically executing acardioprotective pacing protocol specifying a pacing sequence includingalternating pacing and non-pacing periods, or alternating pacing modes.In one embodiment, the pacemaker is an external pacing device such as apacing system analyzer (PSA). In another embodiment, the pacemaker isintegrated into the one of the one or more PTVI devices.

FIG. 1 is an illustration of an embodiment of a system 100 providing forpacing during revascularization and portions of an environment in whichsystem 100 is used. System 100 includes a PTVI device 110, a pacemaker122, and a cable 121 connecting PTVI device 110 and pacemaker 122. Whenneeded, system 100 also includes a reference electrode 119, which is asurface electrode, such as a skin patch electrode, connected to a lead120. Lead 120 is connected to a connector 118 allowing its connection tocable 121.

PTVI device 110 is used during a revascularization procedure andincludes a distal end portion 111 for intravascular placement and aproximal end portion 112. Proximal end portion 112 includes a proximalend device 114 and pacing connectors 116A-B. Proximal end device 114includes various connectors and other structures allowing manipulationof PTVI device 110 including the percutaneous transluminal insertion ofthe device and operation of an angioplasty device at distal end 111.Pacing connectors 116A-B provide for electrical connections betweenpacemaker 122 and PTVI device 110 through cable 121. In the illustratedembodiment, PTVI device 110 is a PTCA device used in a PTCA procedure.During the PTCA procedure, an opening 105 is made on a femoral artery104 in a patient's body 102. PTVI device 110 is inserted into femoralartery 104 and advanced to an aorta 106 and then to a right coronaryartery 107, which is narrowed or blocked. The angioplasty device atdistal end 111 is then used to open up the blocked right coronary artery107. In another embodiment, PTVI device 110 is used to open up a blockedleft coronary artery 108.

Distal end portion 111 of PTVI device 110 includes one or more pacingelectrodes to allow pacing pulses to be delivered to a heart 101 duringthe PTCA procedure. In one embodiment, pacing pulses are deliveredthrough two pacing electrodes on distal end portion 111 of PTVI device110. In another embodiment, pacing pulses are delivered through a pacingelectrode on distal end portion 111 of PTVI device 110 and surfaceelectrode 119 functioning as the return electrode for pacing.

Pacemaker 122 delivers pacing pulses by executing a cardioprotectivepacing protocol. In one embodiment, the cardioprotective pacing protocolspecifies a cardioprotective pacing sequence for preventing arrhythmiasand cardiac injuries associated with the revascularization procedure. Inone embodiment, pacemaker 122 is an external pacemaker such as a PSA. Inanother embodiment, pacemaker 122 includes an implantable pacemakeradapted for external use.

It is to be understood that FIG. 1 is for illustrative, but notrestrictive, purposes. For example, the physical structure of proximalend portion 112 depends on functional and ease-of-use considerations.Proximal end device 114 represents a structure that accommodates all themechanical connection and access requirements, which depend on thespecific configuration and function of PTVI device 110. In oneembodiment, proximal end device 114 includes an integrated device asillustrated in FIG. 1. In another embodiment, proximal end device 114branches out into multiple connectors and/or other devices. Pacingconnectors 116A-B represent a structure that accommodates all theelectrical connections required for delivering pacing pulses frompacemaker 122 to PTVI device 110. The number of pacing connectorsdepends on the number of pacing electrodes incorporated onto PTVI device110 and how it is to be connected to cable 121. In one embodiment, whenmore than one electrical connection is needed for delivering the pacingpulses, proximal end portion 112 includes branched-out pacing connectorssuch as pacing connectors 116 and 117 as illustrated in FIG. 1. Inanother embodiment, proximal end portion 112 includes a single connectorproviding for multiple, independent electrical connections.

Pacemaker

FIG. 2 is a block diagram illustrating an embodiment of an externalpacemaker 222 that provides for pacing during revascularization.External pacemaker 222 is an embodiment of pacemaker 122 and includes apacing output circuit 224, a user interface 228, and a control circuit226. Pacing output circuit 224 delivers pacing pulses to PTVI device 110through cable 121. User interface 228 allows a user to control thedelivery of the pacing pulses by controlling pacing parameters and/ortiming of the delivery. Control circuit 226 controls the delivery of thepacing pulses. In one embodiment, external pacemaker 222 is a PSAincluding a chassis that houses pacing output circuit 224 and controlcircuit 226. User interface 228 is incorporated onto the chassis.

In the illustrated embodiment, control circuit 226 includes a pacingprotocol module 227, which enables control circuit 226 to control thedelivery of the pacing pulses by automatically executing a pacingprotocol. To provide an acute pacing cardioprotection therapy, thepacing protocol specifies a cardioprotective pacing sequence thatincludes alternating pacing and non-pacing periods or alternating pacingmodes for delivering pacing during a revascularization procedure such asa PTCA procedure.

In one embodiment, pacing protocol module 227 is configured to bedetachably connected to external pacemaker 222. In a specificembodiment, pacing protocol module 227 includes a memory device thatstores the cardioprotective pacing protocol, and control circuit 226 iscapable of automatically executing the cardioprotective pacing protocolwhen pacing protocol module 227 is connected to external pacemaker 222.In another specific embodiment, in addition to the memory device thatstores the cardioprotective pacing protocol, pacing protocol module 227includes a user interface that allows the user to adjust parameters ofthe cardioprotective pacing protocol and/or control circuitry thatsupplement the functions of control circuit 226 for automaticallyexecuting the cardioprotective pacing protocol. In various embodiments,other pacing protocol modules are provided for automatically executingpacing protocols using external pacemaker 222. In various embodiments,the user is provided with external pacemaker 222 and pacing protocolmodules for executing pacing protocols such as the cardioprotectivepacing protocol, cardiac resynchronization therapy (CRT) pacingprotocol, and cardiac remodeling control therapy (RCT) pacing protocol.Compared to a PSA that requires the user to manually adjust pacingparameters during a test or therapy session, the automatic execution ofthe pacing protocol increases the accuracy of pacing control and reducesor eliminates the need for the user to control the delivery of thepacing pulses, so that the user can be more attentive to the response ofthe patient and/or the revascularization procedure.

FIG. 3 is a timing diagram illustrating an embodiment of thecardioprotective pacing protocol that specifies a cardioprotectivepacing sequence. The cardioprotective pacing sequence is initiated aftera time interval 301 that starts when the insertion of PTVI device intobody 102 is completed. Time interval 301 expires before, during, and/orafter an ischemic event that occurs when the blood vessel targeted bythe revascularization procedure is substantially occluded by PTVI device110. In one embodiment, the cardioprotective pacing sequence is appliedrepeatedly, before, during, and/or after the occlusion of the bloodvessel, during the revascularization procedure.

As illustrated in FIG. 3, the cardioprotective pacing sequence includesalternating pacing and non-pacing periods. Each pacing period is apacing duration during which the pacing pulses are delivered in apredetermined pacing mode. The non-pacing period is a non-pacingduration during which no pacing pulses is delivered. In one embodiment,during each pacing period, rapid, asynchronous pacing is applied. Inother words, pacing pulses are delivered at a rate substantially higherthan the patient's intrinsic heart rate without being synchronized tothe patient's intrinsic cardiac contractions. For illustrative purposeonly, FIG. 3 shows a cardioprotective pacing sequence that includes twocycles of alternating pacing and non-pacing periods: pacing period 302A,non-pacing periods 303A, pacing period 302B, and non-pacing periods303B. In one embodiment, the number of the cycles of alternating pacingand non-pacing periods is programmable, and each of the pacing andnon-pacing periods is programmable. In one embodiment, thecardioprotective pacing sequence is initiated before the ischemic eventand includes approximately 1 to 4 cycles of alternating pacing andnon-pacing periods. The pacing period is in a range of approximately 30seconds to 20 minutes. The non-pacing period is in a range ofapproximately 30 seconds to 20 minutes. In a specific example, thecardioprotective pacing sequence initiated before the ischemic eventincludes 3 cycles of alternating pacing and non-pacing periods eachbeing approximately 5-minute long. In one embodiment, thecardioprotective pacing sequence is initiated during the ischemic eventand includes approximately 1 to 4 cycles of alternating pacing andnon-pacing periods. The pacing period is in a range of approximately 30seconds to 20 minutes. The non-pacing period is in a range ofapproximately 30 seconds to 20 minutes. In a specific example, thecardioprotective pacing sequence delivered during the ischemic eventincludes 3 cycles of alternating pacing and non-pacing periods eachbeing approximately 5-minute long. In one embodiment, thecardioprotective pacing sequence is initiated after the ischemic eventand includes approximately 1 to 4 cycles of alternating pacing andnon-pacing periods. The pacing period is in a range of approximately 10seconds to one minute. The non-pacing period is in a range ofapproximately 10 seconds to one minute. In one specific example, thecardioprotective pacing sequence delivered after the ischemic eventincludes 2 to 4 cycles of alternating pacing and non-pacing periods eachbeing approximately 30-second long.

In various other embodiments, the cardioprotective pacing sequenceincludes pacing at one or more atrial tracking or other pacing modes.Examples of pacing modes used in such a cardioprotective pacing sequenceinclude VDD, VVI, and DDD modes. In various embodiments, the VVI and DDDmodes are delivered with a lower rate limit higher than the patient'sintrinsic heart rate. In one embodiment, pacing therapy is deliveredwith pacing mode and/or other pacing parameters selected to create oraugment mechanical stress on the myocardium or particular regions of themyocardium. In another embodiment, pacing therapy is delivered toprevent restenosis. In another embodiment, pacing therapy is deliveredto treat an arrhythmia during the revascularization procedure, forexample, when the patient experiences bradycardia during the procedure.

In various embodiments, during the pacing periods, the delivery of thepacing pulse is controlled according to a stress augmentation pacingmode, and during the non-pacing periods of the cardioprotective pacingsequence, no pacing pulse is timed to be delivered according to anon-pacing mode. When a pacing pulse is timed to be delivered, it willbe delivered unless inhibited by an inhibitory event such as a detectedintrinsic cardiac depolarization occurring before the scheduled deliveryof the pacing pulse during a cardiac cycle. Under the non-pacing modeaccording to which no pacing pulse is timed to be delivered, thenon-delivery is due to programming rather than inhibition by a detectedinhibitory event. Under the stress augmentation pacing mode, pacingpulses are delivered to augment mechanical stress on the myocardium ofthe heart to a level effecting cardioprotection against myocardialinjury. In various embodiments, the stress augmentation pacing mode is astandard or non-standard pacing mode with pacing parameter valuesselected for the desired level of myocardial stress augmentationaccording to the patients' needs, conditions, and responses. Examples ofthe stress augmentation pacing mode includes an atrial tracking pacingmode with a relatively short atrioventricular (AV) delay, a bradycardiapacing mode with a pacing rate substantially higher than the patient'sintrinsic heart rate, and an asynchronous pacing mode with a pacing ratesubstantially higher than the patient's intrinsic heart rate.

In one embodiment, the pacing pulses are delivered according to thecardioprotective pacing protocol through PTVI device 110 during therevascularization procedure. After the revascularization procedure, ifan implantable pacemaker is implanted into the patient, pacing therapyis delivered to heart 101 through one or more implantable leads from theimplantable pacemaker. The pacing therapy includes delivering pacingpulses according to a pacing sequence that is substantially identical orsimilar to the cardioprotective pacing sequence applied during therevascularization procedure. The pacing sequence is delivered accordingto a predetermined schedule, such as on a predetermined periodic basis.This prevents or reduces possible cardiac injury after therevascularization, including cardiac injury and occurrences ofarrhythmia caused by ischemic events including myocardial infarctionthat may be experienced by the patient after the implantation of theimplantable pacemaker.

PTVI Device with Pacing Electrode(s)

FIGS. 4-6 illustrate a PTVI device assembly that includes a guidecatheter, a guide wire, and an angioplasty catheter. During arevascularization procedure such as a PTCA procedure, the guide catheteris inserted into the patient first, followed by the guide wire through alumen of the guide catheter. The angioplasty catheter includes a lumenthat accommodates a portion of the guide wire, thereby allowing theangioplasty catheter to be inserted into the patient through the guidecatheter and over the guide wire. The guide catheter, guide wire, andangioplasty catheter are inserted in such a way that allows anangioplasty device, such as a balloon, of the angioplasty catheter to beplaced in the portion of a blocked blood vessel that is to be reopenedduring the revascularization procedure.

FIG. 4 is an illustration of an embodiment of a guide catheter 410.Guide catheter 410 is an embodiment of PTVI device 110 and has anelongate shaft 413 between a distal end portion 411 and a proximal endportion 412. Distal end portion 411 is configured for intravascularplacement and includes a distal tip 435. A lumen 430 extends withinshaft 413 and has a proximal opening in proximal end portion 412 and adistal opening at distal tip 435. Lumen 430 accommodates at least aportion of the angioplasty catheter. Distal end portion 411 includespacing electrodes 432A-B. In the illustrated embodiment, electrode 432Ais incorporated onto distal tip 435. Conductor 433A is connected betweenpacing electrode 432A and a connector 416A. Conductor 433B is connectedbetween pacing electrode 432B and a connector 416B. Connectors 416A-Bare each part of proximal end portion 412. In one embodiment, conductors433A-B each extend longitudinally within shaft 413. In anotherembodiment, conductors 433A-B each extend longitudinally on the outersurface of shaft 413 and are insulated.

In one embodiment, guide catheter 410 has a length in a range ofapproximately 50 cm to 150 cm. Shaft 413 has an outer diameter in arange of approximately 0.5 mm to 8 mm, and lumen 430 has a diameter in arange of approximately 0.4 mm to 7 mm. Conductors 433A-B are made of ametallic material such as stainless steel or an alloy of nickel,titanium, cobalt, gold, and/or silver chloride. Elongate shaft 413 ismade of a material such as silicone, polyurethane, Teflon, orpolytetrafluoroethylene (PTFE). Electrodes 432A-B are made of a metallicmaterial such as platinum or an iridium alloy.

FIG. 5 is an illustration of an embodiment of a guide wire 510. Guidewire 510 is an embodiment of PTVI device 110 and has an elongate shaft513 between a distal end portion 511 and a proximal end portion 512.Distal end portion 511 is configured for intravascular placement andincludes a distal tip 535. Distal end portion 511 includes pacingelectrodes 532A-B. In the illustrated embodiment, electrode 532A isincorporated onto distal tip 535. Conductor 533A is connected betweenpacing electrode 532A and a connector 516A. Conductor 533B is connectedbetween pacing electrode 532B and a connector 516B. Connectors 516A-Bare each part of proximal end portion 512. In one embodiment, conductors533A-B each extend longitudinally within shaft 513. In anotherembodiment, conductors 533A-B each extend longitudinally on the outersurface of shaft 513 and are insulated. In one embodiment, one ofconnectors 533A-B is the core of guide wire 510.

In one embodiment, guide wire 510 has a length in a range ofapproximately 30 cm to 300 cm. Shaft 513 is an elongate cylindricalshaft having a diameter in a range of approximately 0.2 mm to 1.5 mm.Conductors 533A-B are made of a metallic material such as stainlesssteel or an alloy of nickel, titanium, and/or cobalt. Elongate shaft 513is made of a material such as silicone, polyurethane, Teflon, orpolytetrafluoroethylene (PTFE). Electrodes 532A-B are made of a metallicmaterial such as platinum, an iridium alloy, gold, or silver chloride.

FIG. 6 is an illustration of an embodiment of an angioplasty catheter610. Angioplasty catheter 610 is an embodiment of PTVI device 110 andhas an elongate shaft 613 between a distal end portion 611 and aproximal end portion 612. A lumen 631 longitudinally extends withinshaft 613 to accommodate at least a portion of a guide wire such asguide wire 510. Distal end portion 611 is configured for intravascularplacement and includes a distal tip 635 and an angioplasty device 634.Angioplasty device 634 has one end approximately adjacent to distal tip635 and another end coupled to shaft 613. In one embodiment, angioplastydevice 634 includes an adjustable portion that has controllableexpandability and contractibility. In the illustrated embodiment,angioplasty device 634 includes a balloon that is inflated and deflatedthrough a lumen longitudinally extending within shaft 613 and connectedbetween the chamber of the balloon and a connector 614 at proximal endportion 612. The balloon is inflatable using an air or liquid pumpconnected to that connector. In various embodiments, angioplasty device634 includes a balloon or other device that allows for application of anangioplasty therapy such as vascular dilatation, stent delivery,brachytherapy (radiotherapy), atherectomy, or embolic protection. In oneembodiment, distal tip 635 is a tapered tip that facilitates theinsertion of angioplasty catheter 610 into a blood vessel. Distal endportion 611 includes pacing electrodes 632A-B. In the illustratedembodiment, pacing electrode 632A is approximately adjacent to one endof angioplasty device 634, and pacing electrode 632B is approximatelyadjacent to the other end of angioplasty device 634. A conductor 633Aextends longitudinally within shaft 613 and is connected between pacingelectrode 632A and a pacing connector 616A, which is part of proximalend portion 612. A conductor 633B extends longitudinally within elongateshaft 613 and is connected between pacing electrode 632B and a pacingconnector 616B, which is also part of proximal end portion 612. In analternative embodiment, pacing connectors 616A-B are physicallyintegrated into one multi-conductor connector. Proximal end portion 612also includes a proximal end device 614. In various embodiments,connector 614 includes a structure that accommodates all the mechanicalconnection and access requirements for angioplasty catheter 610, whichdepend on the function of angioplasty device 634. In one embodiment,connector 614 includes an integrated device. In another embodiment,connector 614 branches out into multiple connectors and/or otherdevices.

In one embodiment, angioplasty catheter 610 has a length in a range ofapproximately 50 cm to 150 cm. Shaft 613 is an elongate cylindricalshaft having a diameter in a range of approximately 1 mm to 5 mm. In oneembodiment, angioplasty device 634 has an adjustable, substantiallycylindrical or semi-spherical shape with a maximum diameter in a rangeof approximately 1 mm to 10 mm when fully expanded and a maximumdiameter in a range of approximately 0.5 mm to 5 mm when fullycontracted. In one embodiment, conductors 633A-B are each made of ametallic material such as stainless steel or an alloy of nickel,titanium, and/or cobalt. Electrodes 632A-B are each made of a metallicmaterial such as platinum or an iridium alloy. Elongate shaft 613 has atubular outer shell made of a material such as silicone, polyurethane,Teflon, or polytetrafluoroethylene (PTFE).

Guide catheter 410, guide wire 510, and angioplasty device 610 areillustrated in FIGS. 4-6 for illustrative but not restrictive purposes.For example, one or more pacing electrodes can be distributed on each ofthese PTVI devices in any way allowing delivery of pacing pulses todesirable locations. In various embodiments, one or more pacingelectrodes are incorporated onto one or more of guide catheter 410,guide wire 510, and angioplasty device 610 for delivering pacing pulsesthrough the PTVI device assembly including these three devices. In oneembodiment, one or more defibrillation electrodes are also incorporatedonto one or more of guide catheter 410, guide wire 510, and angioplastydevice 610 for delivering defibrillation shocks through the PTVI deviceassembly. In one embodiment, one or more pacing electrodes such as oneof more of pacing electrodes 432A-B, 532A-B, and 632A-B are made ofconductive radiopaque material to function as one or more radiopaquemarkers for locating guide catheter 410, guide wire 510, and/orangioplasty device 610 using fluoroscopy.

In one embodiment, angioplasty device 610 includes a balloon. Guide wire510 remains within lumen 631 when the balloon is inflated. The inflatedballoon is over pacing electrodes 532A-B. When being deflated, theballoon is retracted to expose electrodes 532A-B, thereby allowingdelivery of pacing pulses. In one embodiment, shaft 613 includes aportion having an adjustable length that is shortened to exposeelectrodes 532A-B when the balloon is deflated.

In one application during a PTCA procedure for reopening, for example,right coronary artery 107, guide catheter 410 is inserted into femoralartery 104 and advanced to aorta 106 until distal tip 435 reaches thepoint where right coronary artery 107 branches from aorta 106. Guidewire 510 is introduced through lumen 430 of guide catheter 410 untildistal end 535 is in right coronary artery 107. Angioplasty catheter 610is then introduced through lumen 430 over guide wire 510 untilangioplasty device 634 (balloon) is in the portion of right coronaryartery 107. In one embodiment, the acute pacing cardioprotection therapyis delivered using electrodes 432A-B as soon as guide catheter 410 is inplace for the PTCA procedure. In one embodiment, when the PTVI deviceassembly including guide catheter 410, guide wire 510, and angioplastydevice 610 are in place for the PTCA procedure, the acute pacingcardioprotection therapy is delivered using one or more pairs of pacingelectrodes selected from electrodes 432A-B, 532A-B, 632A-B, and 119.

In one embodiment, the PTVI device assembly allows for combined pacingcardioprotection therapy and ischemic cardioprotection therapy. Forexample, the ischemic cardioprotection therapy is applied byintermittently occluding a blocked vessel by inflating and deflatingangioplasty device 634 (balloon) of angioplasty catheter 610, inaddition to delivering the pacing cardioprotection therapy through theone or more pairs of pacing electrodes.

Various embodiments of the PTVI devices and the pacemaker are discussedbelow as examples illustrating the pacing system for delivering theacute pacing cardioprotection therapy during a revascularizationprocedure. In general, such a pacing system includes a pacemaker capableof delivering pacing pulses according to a cardioprotective pacingprotocol, such as discussed above with reference to FIG. 3, and one ormore PTVI devices each including one or more pacing electrodes. In oneembodiment, the one or more PTVI devices includes devices used toperform the revascularization procedure, such as guide catheters, guidewires, and angioplasty catheters, that are modified to allow delivery ofthe acute pacing cardioprotection therapy. In another embodiment, theone or more PTVI devices includes one or more devices that are notrequired to perform the revascularization procedure itself butconfigured to allow delivery of pacing pulses during therevascularization procedure. In various embodiments, the PTVI deviceshave sizes identical or similar to those discussed above, and areconstructed using materials identical or similar to those discussedabove.

FIGS. 7-13 illustrate several specific embodiments of guide catheter410, guide wire 510, and angioplasty device 610. In various embodiments,pacing pulses are delivered during a revascularization procedure usingany PVTI device with at least one pacing electrode, alone or incombination with any other PTVI device(s) each with at least one pacingelectrode and/or electrode(s) placed in or on the patient receiving therevascularization procedure.

FIG. 7 is an illustration of an embodiment of a distal portion of aguide catheter 710 showing its distal end portion 711 and elongate shaft713. Guide catheter 710 is another embodiment of guide catheter 410. Asshown in FIG. 7, distal end portion 711 includes a distal tip 735 wherea lumen 730 ends with its distal opening. Lumen 730 is configured toaccommodate at least a portion of an angioplasty catheter such asangioplasty catheter 610 and allow the angioplasty device of theangioplasty catheter to exit from guide catheter 710. Pacing electrodes732A-B are incorporated onto distal tip 735, adjacent to the distalopening of lumen 730. Pacing electrodes 732C-D are incorporated ontoshaft 713. Conductors 733A-D provide for electrical connections allowingpacing pulses to be delivered to pacing electrodes 732A-D when thepacemaker is connected to the proximal end of guide catheter 710. Invarious other embodiments, guide catheter 710 includes any number ofpacing electrodes incorporated onto distal end portion 711 and/or shaft713. In various embodiments, any one or more of the pacing electrodesincorporated onto guide catheter 710 are selected for delivering thepacing pulses during a revascularization procedure.

FIG. 8 is an illustration of an embodiment of a distal end portion of aguide catheter 810 showing its distal end portion 811 and elongate shaft813. Guide catheter 810 is another embodiment of guide catheter 410. Asshown in FIG. 8, distal end portion 811 includes a distal tip 835 wherea lumen 830 ends with its distal opening. Lumen 830 is configured toaccommodate at least a portion of an angioplasty catheter such asangioplasty catheter 610 and allow the angioplasty device of theangioplasty catheter to exit from guide catheter 810. A pacing electrode832 configured as a coil electrode is incorporated onto distal endportion 811 near distal tip 835. A conductor 833 provides for electricalconnection allowing pacing pulses to be delivered to pacing electrode832 when the pacemaker is connected to the proximal end of guidecatheter 810. In various other embodiments, guide catheter 810 includesany number of coil electrodes incorporated onto distal end portion 811and/or shaft 813. In various embodiments, any one or more coilelectrodes incorporated onto guide catheter 810 are selected fordelivering the pacing pulses during a revascularization procedure.

FIG. 9 is an illustration of an embodiment of the distal portion of aguide catheter 910 showing its distal end portion 911 and elongate shaft913. Guide catheter 910 is another embodiment of guide catheter 410. Asshown in FIG. 9, distal end portion 911 includes a distal tip 935 wherea lumen 930 ends with its distal opening. Lumen 930 is configured toaccommodate at least a portion of an angioplasty catheter such asangioplasty catheter 610 and allow the angioplasty device of theangioplasty catheter to exit from guide catheter 910. A pacing electrode932A is configured as a collar electrode and incorporated onto distaltip 935. Another pacing electrode 932B is configured as another collarelectrode and incorporated onto shaft 913. Two layers of tubular metalbraid each extend within guide catheter 910 and connect to one of pacingelectrodes 932A-B. These two layers of tubular metal braid function asconductors 933A-B, which provide for electrical connections allowingpacing pulses to be delivered to pacing electrodes 932A-B when thepacemaker is connected to the proximal end of guide catheter 910. Invarious other embodiments, guide catheter 910 includes any number ofcollar electrodes incorporated onto distal end portion 911 and/or shaft913. In various embodiments, any one or more collar electrodesincorporated onto guide catheter 910 are selected for delivering thepacing pulses during a revascularization procedure.

FIG. 10 is an illustration of an embodiment of the distal portion of aguide wire 1010 showing its distal end portion 1011 and elongate shaft1013. Guide wire 1010 is another embodiment of guide wire 510 and isformed by a conductor 1033 covered by an insulation layer 1043. In theillustrated embodiment, distal end portion 1011 includes a distal tip1035 and a pacing electrode 1032 formed by an opening in insulationlayer 1043 that exposes a portion of conductor 1033. Pacing pulses aredelivered through conductor 1033 to the patient throughopening/electrode 1032 when the pacemaker is connected to the proximalend of guide wire 1010. In various other embodiments, insulation layer1043 includes any number of openings functioning as electrodes on distalend portion 1011 and/or shaft 1013.

FIG. 11 is an illustration of an embodiment of the distal portion of aguide wire 1110 showing its distal end portion 1111 and elongate shaft1113. Guide wire 1110 is another embodiment of guide wire 510 and isformed by a plurality of conductors covered by an insulation layer. Inthe illustrated embodiment, guide wire 1110 includes conductors 1133A-Bthat are insulated to form shaft 1113 and exposed to form pacingelectrodes 1132A-B at distal end portion 1111. Pacing electrodes 1132A-Binclude exposed portions of conductors 1133A-B in a helical formextending to a distal tip 1135 of guide wire 1110. In one embodiment,pacing electrodes 1132A-B are separated from each other to be used as ananode and a cathode for delivering the pacing pulses when the pacemakeris connected to the proximal end of guide wire 1110. In various otherembodiments, guide wire 1110 includes one, two, or more than twoconductors with their distal end portions exposed and configured tofunction as one, two, or more electrically separated pacing electrodes.

FIG. 12 is an illustration of an embodiment of the distal portion of anangioplasty catheter 1210. Angioplasty catheter 1210 is anotherembodiment of angioplasty catheter 610. Distal end portion 1211 includesa balloon 1234 coupled between a distal tip 1235 and an elongate shaft1213. In the illustrated embodiment, balloon 1234 includes perfusionchannels 1236A-B and cutting blades 1232E-F. Perfusion channels 1236A-Beach include a lumen having a proximal opening and a distal opening toallow blood to flow through balloon 1234 when it is inflated. In oneembodiment, when balloon 1234 is inflated, the lumen has a diameter thatallows the distal end portion of a pacing lead to enter its proximalopening and exit from its distal opening such that one or more pacingelectrodes of the pacing lead are placed distal to the lumen. Cuttingblades 1232E-F cut plaques in a blood vessel as balloon 1234 is beinginflated in that blood vessel. In one embodiment, cutting blades 1232E-Fare each made of metal and used as a pacing electrode. In variousembodiments, balloon 1234 is a perfusion balloon including one or moreperfusion channels and/or a cutting balloon including one or morecutting blades. Angioplasty catheter 1210 also includes pacingelectrodes 1232A-D. Pacing electrode 1232A is incorporated onto distaltip 1235. Pacing electrode 1232B is incorporated onto shaft 1213. Pacingelectrodes 1232C-D are incorporated onto balloon 1234. In oneembodiment, one or more of pacing electrodes 1232A-D are made ofradiopaque material to function as one or more radiopaque markers forlocating distal end portion 1211 using fluoroscopy. Conductors 1233A-Fprovide for electrical connections allowing pacing pulses to bedelivered to pacing electrodes 1232A-F when the pacemaker is connectedto the proximal end of angioplasty catheter 1210. In the illustratedembodiment, angioplasty catheter 1210 includes pacing electrodes1232A-F. In various embodiments, angioplasty catheter 1210 includes anyone or more of pacing electrodes 1232A-F as well as other one or morepacing electrodes incorporated onto distal end portion 1211 and/or shaft1213. In various embodiments, any one or more pacing electrodesincorporated onto angioplasty catheter 1210 are selected for deliveringthe pacing pulses during a revascularization procedure.

A potential advantage for using one or more of pacing electrodes 1232C-Ffor delivering pacing pulses is that when balloon 1234 is inflated, thepacing electrodes are pressed onto the vascular wall to form stableelectrical contacts. In one embodiment, a pacing lead that issubstantially identical or similar to guide wire 510 is introduced alongthe side of angioplasty catheter 1210, with its one or more pacingelectrodes placed over balloon 1234 such that when balloon 1234 isinflated, the one or more pacing electrodes of that pacing lead issecurely pressed onto the vascular wall to form a stable electricalcontact for delivering pacing pulses.

FIG. 13 is an illustration of an embodiment of the proximal portion ofan angioplasty catheter 1310 showing a proximal end portion 1312 and anelongate shaft 1313. In the illustrated embodiment, angioplasty catheter1310 includes conductors 1333A-D connected between ring connectors1316A-D in proximal end portion 1312 and pacing electrodes in the distalend portion of angioplasty catheter 1310. In various embodiments,angioplasty catheter 1310 includes one or more conductors and ringconnectors, depending on the number of pacing electrodes. A lumen 1330extends longitudinally within angioplasty catheter 1310 to accommodate aguide wire such as guide wire 510 and/or to allow inflation anddeflation of a balloon at the distal end portion. Lumens 1339A-D eachaccommodates one of conductors 1333A-D.

FIGS. 14-37 illustrate various specific examples of PTVI devices thatinclude pacing electrodes to allow an acute pacing cardioprotectiontherapy to be delivered during a revascularization procedure. In variousembodiments, each of these PTVI devices may function as one of the guidecatheter, guide wire, and angioplasty catheter as discussed above, or aPTVI pacing device that is otherwise not required for therevascularization procedure. In various embodiments, pacing pulses aredelivered from an external pacemaker connected to one or more PTVIdevices with pacing electrodes, or from a pacemaker incorporated onto aPTVI device.

Example: Pacing Catheter with Expandable Distal End

FIGS. 14-18 illustrate various embodiments of a pacing catheterincluding an expandable distal end including one or more pacingelectrodes. When expanded in a blood vessel during a revascularizationprocedure, the distal end is stabilized in the blood vessel to providereliable electrical contact(s) between the one or more pacing electrodesand the vascular wall for delivering pacing pulses.

FIG. 14 is an illustration of an embodiment of a pacing catheter 1410.Pacing catheter 1410 is a PTVI device assembly including a sheath 1410Aand a pacing lead 1410B. Sheath 1410A includes a sheath proximal endportion 1412A, a sheath distal end portion 1411A configured forintravascular placement and including a distal tip 1435A, an elongatesheath shaft 1413A coupled between proximal end portion 1412A and distalend portion 1411A, and a lumen 1430A. Lumen 1430A extends within shaft1413A and has a proximal opening 1441A at proximal end portion 1412A anda distal opening 1440A at distal tip 1435A. In one embodiment, sheath1410A is a guide catheter for use in a revascularization procedure. Inthe illustrated embodiment, sheath 1410A includes a pacing electrode1432A incorporated onto distal end portion 1411A, a connector 1416Aincorporated onto proximal end portion 1412A, and a conductor 1433Aproviding for electrical connection between pacing electrode 1432A andconnector 1416A. In various other embodiments, sheath 1410A includes anynumber of pacing electrodes, or no pacing electrode.

Pacing lead 1410B includes a lead proximal end portion 1412B, anexpandable lead distal end portion 1411B configured for intravascularplacement, and an elongate lead shaft 1413B coupled between proximal endportion 1412B and distal end portion 1411B. Pacing lead 1410B isconfigured to allow distal end portion 1411B to enter lumen 1430Athrough proximal opening 1441A and exit from lumen 1430A through distalopening 1440A by being pushed into lumen 1430A, and retract into lumen1430A through distal opening 1440A and exit lumen 1430A from proximalopening 1441A by being pulled from lumen 1430A. Distal end portion 1411Bincludes a pacing electrode 1432B. Pacing lead 1410B includes aconnector 1416B electrically connected to pacing electrode 1432B via aconductor 1433B extending through shaft 1413B. In one embodiment, pacingelectrode 1432B is incorporated onto distal end portion 1411B. Inanother embodiment, pacing electrode 1432B includes the entire distalend portion 1411B or a substantial portion thereof. Distal end portion1411B is in a contracted state while being placed in lumen 1430A and inan expanded state after exiting from lumen 1430A. In one embodiment,distal end portion 1411B expands upon exiting from lumen 1430A andcontracts upon retracting into lumen 1430A. In one embodiment, distalend portion 1411B is self-expandable and is in an expanded state whennot being restrained. When being placed in a blood vessel and in itsexpanded state, distal end portion 1411B provides for a stableelectrical contact between pacing electrode 1432B and the vascular wallfor delivering pacing pulses.

In various embodiments, pacing lead 1410B includes one or more pacingelectrodes, one or more connectors, and one or more conductors extendingthrough shaft 1413B and connecting between one of the one or more pacingelectrodes and one of the one or more connectors. FIGS. 15-17 illustratevarious embodiments of distal end portion 1411B each including one ormore pacing electrodes.

FIG. 15 is an illustration of an embodiment of a lead distal end portion1511B of a pacing lead 1510B, which is another embodiment of pacing lead1410B. Pacing lead 1510B includes a pacing electrode 1532B at distal endportion 1511B connected to a conductor 1533B extending in an elongatelead shaft 1513B. Pacing electrode 1532B is formed by a wire thatsprings into a coil upon exiting from lumen 1430A from distal opening1440A. The coil has a diameter suitable for stabilizing lead distal end1511B in a blood vessel.

FIG. 16 is an illustration of an embodiment of a lead distal end portion1611B of a pacing lead 1610B, which is another embodiment of pacing lead1410B. Pacing lead 1610B includes a pacing electrode 1632B at distal endportion 1611B connected to a conductor 1633B extending in an elongatelead shaft 1613B. Pacing electrode 1632B includes a Guglielmi DetachableCoil (GDC®). GDC is a coil made of memory material that is restrainedduring delivery into the body and expands when it is no longerrestrained. The coil is electrically sensitive such that it is detachedfrom its delivery device by passing a low-amplitude electrical currentthrough the delivery device. Thus, pacing electrode 1632B expands uponexiting from lumen 1430A from distal opening 1440A and is disconnectedfrom shaft 1613B after the delivery of the pacing pulses.

FIG. 17 is an illustration of an embodiment of a lead distal end portion1711B of a pacing lead 1710B, which is another embodiment of pacing lead1410B. In the illustrated embodiment, pacing lead 1710B includes pacingelectrodes 1732BA and 1732BB at distal end portion 1711B connected toconductors 1733BA and 1733BB extending in an elongate lead shaft 1713B.Conductors 1733BA and 1733BB at distal end 1711B are substantiallyunbiased while being restrained in lumen 1430A and biased when distalend portion 1711B has exited from lumen 1430A from distal opening 1440A.The biased portion of conductors 1733BA and 1733BB are made of one ormore memory materials and configured to be suitable for stabilizingdistal end portion 1711B in a blood vessel when biased. In variousembodiments, distal end portion 1711A includes a plurality of wires eachbeing substantially unbiased when being restrained in lumen 1430A andbiased when not being restrained. The plurality of wires forms one ormore pacing electrodes.

FIG. 18 is an illustration of an embodiment of a PTVI device assembly1810 including a pacing lead 1810B and a balloon catheter 1810A. Ballooncatheter 1810A is an angioplasty catheter including a catheter proximalend portion 1812A, a catheter distal end portion 1811A configured forintravascular placement and including a catheter distal tip 1835A and aballoon 1834A, an elongate catheter shaft 1813A between proximal endportion 1812A and distal end portion 1811A. A pacing electrode 1832A isincorporated onto distal tip 1835A. A conductor 1833A extends withinshaft 1813A and provides for electrical connection between pacingelectrode 1832A and a connector 1816A at proximal end portion 1812A.

Pacing lead 1810B includes a lead proximal end 1812B, a lead distal end1811B including a distal tip 1835B, and an elongate lead shaft 1813Bbetween proximal end portion 1812B and distal end portion 1811B. Apacing electrode 1832B is incorporated onto distal tip 1835B. Aconductor 1833B extends within shaft 1813B and provides for electricalconnection between pacing electrode 1832B and a connector 1816B atproximal end portion 1812B.

To deliver pacing pulses using pacing electrodes 1832A and 1832B, pacinglead 1810B is placed such that pacing electrode 1832B is over balloon1834A when distal end portions 1811A and 1811B are positioned in theintended pacing site in a blood vessel. When balloon 1834A is inflated,pacing electrode 1832B is pressed by balloon 1834A onto the interiorwall of the blood vessel to provide a stable electrical contact fordelivering the pacing pulses. In one embodiment, PTVI device assembly1810 allows for delivering combined ischemic cardioprotection therapy byinflating and deflating balloon 1834A and pacing cardioprotectiontherapy by delivering cardioprotective pacing via electrodes 1832A and1832B.

Example: Pacing Catheter for Access to Multiple Vessels

FIGS. 19 and 20 illustrate various embodiments of a pacing catheterthrough which multiple pacing leads are introduced into multiple bloodvessels. The pacing catheter includes exit ports arranged according tothe anatomy of a portion of the vascular system where the intendedpacing sites are located, such that the pacing leads exit from thepacing catheter through the exit ports into the blood vessels in whichthe pacing electrodes are to be placed. For example, after the pacingcatheter is inserted into a major blood vessel, such as the vessel to bereopened during a revascularization procedure, the pacing leads exitfrom the exit ports to enter the major blood vessel and/or one or moreblood vessels branching from the major blood vessel.

FIG. 19 is an illustration of an embodiment of a pacing catheter 1910.Pacing catheter 1910 is a PTVI device assembly including multiple pacingleads for access to multiple vessels. In the illustrated embodiment,pacing catheter 1910 includes pacing leads 1910A and 1910B and acatheter 1910C.

Pacing lead 1910A includes a lead proximal end portion 1912A including aconnector 1916A, a lead distal end portion 1911A configured forintravascular placement and including a lead distal tip 1935A, and anelongate lead shaft 1913A coupled between lead proximal end portion1912A and lead distal end portion 1911A. A pacing electrode 1932A isincorporated onto distal tip 1935A. A connector 1933A provides forelectrical connection between pacing electrode 1932A and connector1916A.

Pacing lead 1910B includes a lead proximal end portion 1912B including aconnector 1916B, a lead distal end portion 1911B configured forintravascular placement and including a lead distal tip 1935B, and anelongate lead shaft 1913B coupled between lead proximal end portion1912B and lead distal end portion 1911B. A pacing electrode 1932B isincorporated onto distal tip 1935B. A connector 1933B provides forelectrical connection between pacing electrode 1932B and connector1916B.

Catheter 1910C includes a catheter proximal end portion 1912C includinga connector 1916C, a catheter distal end portion 1911C configured forintravascular placement and including a catheter distal tip 1935C, andan elongate catheter shaft 1913C coupled between catheter proximal endportion 1912C and catheter distal end portion 1911C. A pacing electrode1932C is incorporated onto distal tip 1935C. A connector 1933C providesfor electrical connection between pacing electrode 1932C and connector1916C. Catheter 1910C includes one or more entry ports 1943C at proximalend portion 1912C, exit port 1942CA at distal tip 1935C, and exit port1942CB on shaft 1913C. To deliver pacing pulses, distal ends 1911A-B ofpacing leads 1910A-B are inserted into catheter 1910C through entryport(s) 1943C and exit through exit ports 1942CA-B. Exit ports 1942CA-Bare positioned to allow distal ends 1911A-B to enter two blood vesselswhere pacing electrodes 1932A-B are to be placed. In one embodiment,exit port 1942CA is positioned on catheter 1910C to allow pacingelectrode 1932A to be placed in a main blood vessel into which catheter1910C is placed, and pacing electrode 1932B is to be placed in anotherblood vessel branched from the main blood vessel.

In one application, exit ports 1942CA-B are positioned to allow distalend portions 1911A-B to enter the left anterior descending (LAD)coronary artery and the right coronary artery.

In various embodiments, PTVI device assembly 1910 includes two or morepacing leads that are introduced through catheter 1910C, which includestwo or more exit ports each allow one of the pacing leads to exit into ablood vessel. Each of the two or more pacing leads includes one or morepacing electrodes.

FIG. 20 is an illustration of an embodiment of a catheter 2010C, whichis an embodiment of catheter 1910C. Catheter 2010C includes a catheterproximal end portion 2012C, a catheter distal end portion 2011Cconfigured for intravascular placement and including a catheter distaltip 2035C, and an elongate catheter shaft 2013C coupled between catheterproximal end portion 2012C and catheter distal end portion 2011C.Catheter 2010C includes entry ports 2043CA-B at proximal end portion2012C, exit port 2042CB at distal tip 2035C, exit port 2042CA on shaft2013C, and guiding channels 2044CA-B each including a lumen extendingwithin a portion of shaft 2013C. Guiding channel 2044CA includes a lumenconnecting entry port 2043CA and exit port 2042CA. Guiding channel2044CB includes a lumen connecting entry port 2043CB and exit port2042CB. To deliver the pacing pulses, pacing leads 1910A-B are eachplaced using one of guiding channel 2044CA-B, with the distal tipentering one of entry port 2043A-B and exiting from one of exit port2042A-B.

Example: Pacing Catheter Releasing Conductive Liquid as Electrode

FIGS. 21-23 illustrate various embodiments of a pacing catheter thatincludes a pacing electrode and releases a conductive liquid into ablood vessel to provide a conductive medium between a pacing electrodeof the vascular wall of the blood vessel. This conductive mediumincreases electrical conductivity between the pacing electrode and thetarget tissue, thereby lowering the pacing energy required to capturethe heart. In various embodiments, the conductive liquid has anelectrical conductivity that is substantially higher than the electricalconductivity of blood.

FIG. 21 is an illustration of an embodiment of a pacing catheter 2110(cross-sectional view), which releases a conductive liquid 2146, and aninjection device 2150. Pacing catheter 2110 is a PTVI device including aproximal end portion 2112, a distal end portion 2111 configured forintravascular placement and including a distal tip 2135, an elongateshaft 2113 coupled between proximal end portion 2112 and distal endportion 2111, a lumen 2148 extending within shaft 2113, and exit ports2147A-B. Lumen 2148 has a proximal opening 2149 at proximal end portion2112 and connects to exit ports 2147A-B. Conductive liquid 2146 isinjected into lumen 2148 from injection device 2150 through proximalopening 2149 and exits into a blood vessel from lumen 2148 through exitports 2147A-B.

Pacing catheter 2110 includes a pacing electrode 2132 incorporated ontodistal tip 2135, a connector 2116 at proximal end portion 2112, and aconductor 2133 providing for electrical connection between pacingelectrode 2132 and connector 2116. After being released into the bloodvessel, conductive liquid 2146 improves electrical conductivity betweenpacing electrode 2132 and the vascular wall, thereby reducing theimpedance between the pair of anode and cathode through which pacingpulses are delivered. In one embodiment, conductive liquid 2146 includessaline. In one embodiment, conductive liquid 2146 is radiopaque. In oneembodiment, conductive liquid 2146 includes saline and radiopaquecontrast liquid, such as a mixture of approximately 50% of saline and50% of the radiopaque contrast liquid.

In one embodiment, exit ports 2147A-B are configured to allowcontrollable release of conductive liquid 2146 into the blood vessel. Inone embodiment, exit ports 2147A-B each include electrically activatedpolymer (EAP) functioning as a valve that is controlled by an electricfield applied using electrode 2132. While one pacing electrode 2132 andtwo exit ports 2147A-B are shown in FIG. 21 for illustrative purposes,in various embodiments, pacing catheter 2110 includes any number ofpacing electrode(s) and any number of exit port(s) arranged to releaseconductive liquid to increase the electrical conductivity between thepacing electrode(s) and the target tissue for pacing.

FIG. 22 is an illustration of an embodiment of a pacing catheter 2210releasing conductive liquid 2146. Pacing catheter 2210 is a PTVI deviceincluding a proximal end portion 2212, a distal end portion 2211configured for intravascular placement and including a distal tip 2235and a drip balloon 2234, an elongate shaft 2213 coupled between proximalend portion 2212 and distal end portion 2211, a lumen 2248 extendingwithin shaft 2213, and exit ports 2247A-D. Lumen 2248 has a proximalopening 2249 at proximal end portion 2212 and connects to exit ports2247A-D. Conductive liquid 2146 is injected into lumen 2248 frominjection device 2150 through proximal opening 2249 and exit into ablood vessel from lumen 2248 through exit ports 2147A-D.

Pacing catheter 2210 includes a pacing electrode 2232 incorporated ontodrip balloon 2234, a connector 2216 at proximal end portion 2212, and aconductor 2233 providing for electrical connection between pacingelectrode 2232 and connector 2216. Drip balloon 2234 includes a wall2251 forming a chamber 2252 to contain conductive liquid 2146. Wall 2251includes holes functioning as exit ports 2247A-D, which allow fordripping of conductive liquid 2146 from chamber 2252 to the bloodvessel. In one embodiment, the holes are opened to allow for dripping ofconductive liquid 2146 to the blood vessel when drip balloon 2234 isinflated. After being released into the blood vessel, conductive liquid2146 improves electrical conductivity between pacing electrode 2232 andthe vascular wall.

In one embodiment, injection device 2150 injects conductive liquid 2146into chamber 2252 through lumen 2248 to inflate drip balloon 2234 andwithdraws conductive liquid 2146 from chamber 2252 through lumen 2248 todeflate drip balloon 2234. This allows for delivering combined ischemiccardioprotection therapy by inflating and deflating drip balloon 2234and pacing cardioprotection therapy by delivering cardioprotectivepacing via pacing electrode 2232 and conductive liquid 2146.

While four exit ports 2247A-D are shown in FIG. 22 for illustrativepurposes, pacing catheter 2210 includes any number of exit port(s). Inone embodiment, pacing catheter 2210 allows for delivering combinedischemic cardioprotection therapy by inflating and deflating dripballoon 2234 and pacing cardioprotection therapy by deliveringcardioprotective pacing via electrodes 2232 and conductive liquid 2146.

FIG. 23A is a side view, and FIG. 23B is a cross-sectional view,illustrating an embodiment of a pacing catheter 2310 releasingconductive liquid 2146. Pacing catheter 2310 is a PTVI device includinga proximal end portion 2312, a distal end portion 2311 configured forintravascular placement and including a distal tip 2335, and an elongateshaft 2313 coupled between proximal end portion 2312 and distal endportion 2311. Pacing catheter 2310 includes an inner tube 2354 includinga lumen 2348 and an outer tube 2353 accommodating at least a portion ofinner tube 2354. Inner tube includes inner orifices 2347BA-B. Outer tube2353 includes outer orifices 2347AA-B. The release of conductive liquid2146 from lumen 2348 is controlled by rotating inner tube 2354 relativeto outer tube 2353 to create an opening by aligning inner orifices2347BA-B and outer orifices 2347AA-B. Lumen 2348 has a proximal opening2349 at proximal end portion 2312 and connects inner orifices 2347BA-B.Conductive liquid 2146 is introduced into lumen 2348 from injectiondevice 2150 through proximal opening 2349. When aligned, orifices 2347AAand 2347BA form an exit port, and orifices 2347BA and 2347BB formanother exit port, to allow conductive liquid 2146 to flow from lumen2348 to the blood vessel.

Pacing catheter 2310 includes a pacing electrode 2332 incorporated ontodistal end portion 2311, a connector 2316 at proximal end portion 2312,and a conductor 2333 providing for electrical connection between pacingelectrode 2332 and connector 2316. After being released into the bloodvessel, conductive liquid 2146 improves electrical conductivity betweenpacing electrode 2332 and the vascular wall.

While two pairs of inner and outer orifices forming two exit ports areshown in FIG. 23 for illustrative purposes, pacing catheter 2310includes any number of pairs of inner and outer orifices forming anynumber of exit ports.

Example: Pacemaker Integrated with PTVI Device

FIGS. 24-28 illustrate various embodiments of a pacemaker and pacingelectrodes integrated with a PTVI device. Such an integratedpacemaker-PTVI device eliminates the need for connecting a separatepacemaker to a PTVI device, thereby simplifying the equipment setup forpacing during a revascularization procedure.

FIG. 24 is an illustration of an embodiment of a pacemaker 2456integrated with a PTVI device 2410. PTVI device 2410 includes a proximalend portion 2412, a distal end portion 2411 configured for intravascularplacement and including a distal tip 2435, and an elongate shaft 2413coupled between proximal end portion 2412 and distal end portion 2411.In the illustrated embodiment, pacemaker 2456 is incorporated onto shaft2413. Pacing electrodes 2432A-B are incorporated onto distal end portion2411 and electrically connected to pacemaker 2456 via conductors2433A-B. In various embodiments, PTVI device 2410 includes any number ofpacing electrodes incorporated onto one or more of distal end portion2411 and shaft 2413. Examples of PTVI device 2410 include a guide wire,a guide catheter, and an angioplasty catheter. In various embodiments,pacemaker 2456 is integrated into any of the PTVI devices discussed inthe document.

FIG. 25 is an illustration of an embodiment of a pacemaker 2556.Pacemaker 2556 is an embodiment of 2456 and includes a flexiblepacemaker circuit including an electronic circuit 2559 and a battery2558 both built on a flexible circuit substrate 2557. Flexible circuitsubstrate 2557 is affixed to PTVI device 2410. In one embodiment,electronic circuit 2559 includes a pacing output circuit such as pacingoutput circuit 224 and a control circuit such as control circuit 226. Inone embodiment, battery 2558 is a solid state battery, such as a solidstate lithium battery, deposited on flexible circuit substrate 2557. Inone embodiment, battery 2558 is capable of providing electronic circuit2559 with energy for delivering pacing pulses according to thecardioprotective pacing protocol for about 10 minutes.

In one embodiment, electronic circuit 2559 includes a control circuitthat initiates the delivery of pacing pulses when pacing electrodes2432A-B contact blood, such as when distal end portion 2411 exits from aguide catheter or other sheath. In another embodiment, electroniccircuit 2559 is communicatively coupled to an external device via awired or wireless communication link, and initiates the delivery ofpacing pulses in response to a command received from the externaldevice. In another embodiment, electronic circuit 2559 includes a switchthat is mechanically controlled through a string, a sheath, or othermechanical link extending within or over PTVI device 2410. The switchallows initiation, suspension, and/or termination of the delivery ofpacing pulses at proximal end portion 2412. In one embodiment, theduration of the delivery of pacing pulses is programmed into electroniccircuit 2559. For example, the electronic circuit 2559 is programmed toexecute the cardioprotective pacing protocol discussed above withreference to FIG. 3, and the delivery of the pacing pulses is terminatedwhen the pacing sequence specified by the cardioprotective pacingprotocol is completed. In circumstances of emergency, such as whenfibrillation is detected, the delivery of pacing pulses is stopped by acommand from the external device or the mechanically controlled switch,whichever is available, or by removing PTVI device 2410 from thepatient.

FIG. 26 is an illustration of an embodiment of pacemaker 2456 integratedwith a PTVI device 2610. PTVI device 2610 is another embodiment of PTVIdevice 2410 and includes a proximal end portion 2612, a distal endportion 2611 configured for intravascular placement and including adistal tip 2635, and an elongate shaft 2613 coupled between proximal endportion 2612 and distal end portion 2611. Pacemaker 2456 is incorporatedonto proximal end portion 2612. Pacing electrodes 2432A-B areincorporated onto distal end portion 2611 and electrically connected topacemaker 2456 via conductors 2633A-B.

FIG. 27 is an illustration of an embodiment of pacemaker 2456 integratedwith a PTVI device 2710. PTVI device 2710 is another embodiment of PTVIdevice 2410 and includes a proximal end portion 2712, a distal endportion 2711 configured for intravascular placement and including adistal tip 2735, and an elongate shaft 2713 coupled between proximal endportion 2712 and distal end portion 2711. Pacemaker 2456 is incorporatedonto shaft 2713. A pacing electrode 2732A is incorporated onto distalend portion 2711 and electrically connected to pacemaker 2456 via aconductor 2733A. Another pacing electrode 2732B is incorporated ontoshaft 2713 and electrically connected to pacemaker 2456 via a conductor2733B.

FIG. 28 is an illustration of an embodiment of a pacemaker 2856integrated into a PTVI device 2810. PTVI device 2810 is anotherembodiment of PTVI device 2410 and includes a proximal end portion 2812,a distal end portion 2811 configured for intravascular placement andincluding a distal tip 2835, and an elongate shaft 2813 coupled betweenproximal end portion 2812 and distal end portion 2811. Pacemaker 2856includes a flexible pacemaker circuit including electronic circuit 2559,solid state battery 2558, and pacing electrodes 2832A-B, all of whichbuilt on flexible circuit substrate 2557. In other words, pacemaker 2856includes pacemaker 2456 and pacing electrodes 2832A-B built on aflexible circuit substrate, where pacing electrodes 2832A-B areelectrically connected to pacemaker 2456.

PTVI devices 2410, 2610, 2710, and 2810 are discussed above forillustrative purposes. In various embodiment, a pacemaker such aspacemaker 2456 or 2856 and two or more pacing electrodes are integratedinto a PTVI device for delivering pacing pulses during arevascularization procedure. In various embodiments, the PTVI devicewith which the pacemaker is integrated includes any PTVI devicediscussed in this document. In one embodiment, such a PTVI deviceincluding built-in pacemaker and pacing electrodes are constructed as adisposable device for a single use.

Example: Angioplasty Catheter with Pacing Electrodes on Shaft

FIGS. 29-33 illustrate various examples of one or more pacing electrodesincorporated onto the shaft of an angioplasty catheter such as a ballooncatheter. In its expanded state, such as when a balloon is inflated, theangioplasty device at the distal end portion of the angioplasty catheterfunctions as an anchor to stabilize the location of the pacingelectrode(s) in a blood vessel. In one embodiment, the one or morepacing electrodes are displaceable along the shaft of the angioplastycatheter. This allows, for example, the pacing site(s) to be positionedupstream and away from the infarcted region, thereby lowering the energyrequired to capture the heart by delivering pacing pulses to normaltissue, which is known to be less conductive than infarct tissue. Inanother embodiment, the angioplasty catheter includes an outer shellmade of conductive material, and at least a portion of the outer shellfunctions as a pacing electrode.

FIG. 29 is an illustration of an embodiment of an angioplasty catheter2910. Angioplasty catheter 2910 is a PTVI device that includes aproximal end portion 2912, a distal end portion 2911 configured forintravascular placement and including an angioplasty device 2934 and adistal tip 2935, and an elongate shaft 2913 coupled between proximal endportion 2912 and distal end portion 2911. In the illustrated embodiment,a sleeve 2960 is placed over shaft 2913. Pacing electrodes 2932A-B areincorporated onto sleeve 2960 and electrically connected to connectors2916A-B at proximal end portion 2912 via conductors 2933A-B. Sleeve 2960includes a first lumen 2961 and a second lumen 2962. Lumen 2961 isconfigured to accommodate a portion of shaft 2913 and allow sleeve 2960with electrodes 2932A-B to slide over shaft 2913. Conductors 2933A-Beach have an adjustable length, displaceable along shaft 2913, orotherwise flexible to allow the displacement of sleeve 2960 over shaft2913. Lumen 2962 is configured to receive a push wire 2963 for movingsleeve 2960 along shaft 2913.

In one embodiment, angioplasty device 2934 includes a balloon. Wheninflated, balloon 2934 functions as an anchor to stabilize the locationsof pacing electrodes 2932A-B. For example, after expanding balloon 2934,electrodes 2932A-B are positioned by sliding sleeve 2960 along shaft2913. In various embodiments, angioplasty catheter 2910 includes one ormore sleeves over shaft 2913. Each sleeve includes one or more pacingelectrodes.

FIG. 30 is an illustration of an embodiment of a sleeve 3060, which isan embodiment of sleeve 2960 and is configured to be placed over shaft2913. Sleeve 3060 is a flexible C-shaped sleeve including a slit 3063, afirst lumen 3061, a second lumen 3062, and pacing electrodes 2932A-B.Slit 3063 extends longitudinally along sleeve 3060 to allow sleeve 3060to be pushed onto shaft 2913 and peeled away from shaft 2913. Lumen 3061is configured to accommodate a portion of shaft 2913 and allow sleeve3060 to slide along a portion of shaft 2913. Lumen 3062 is configured toreceive a push wire allowing sleeve 3060 to be pushed to slide alongshaft 2913.

FIG. 31 is an illustration of an embodiment of an angioplasty catheter3110, which is another embodiment of angioplasty catheter 2910.Angioplasty catheter 3110 is a PTVI device that includes a proximal endportion 3112, a distal end portion 3111 configured for intravascularplacement and including angioplasty device 2934 and a distal tip 3135,and an elongate shaft 3113 coupled between proximal end portion 3112 anddistal end portion 3111. In the illustrated embodiment, pacingelectrodes 3132A-B, each configured as a stent, are placed over shaft3113 and electrically connected to connectors 3116A-B at proximal endportion 3112 via conductors 3133A-B. In one embodiment, pacingelectrodes 3132A-B are each configured as a flexible stent. In oneembodiment, conductors 3133A-B each have an adjustable length,displaceable along shaft 3113, or otherwise flexible to allow thedisplacement of pacing electrodes 3132A-B over shaft 3113. In variousembodiments, angioplasty catheter 3110 includes one or more pacingelectrodes configured as one or more stents over shaft 3113.

FIG. 32 is an illustration of an embodiment of an angioplasty catheter3210. Angioplasty catheter 3210 is a PTVI device that includes aproximal end portion 3212, a distal end portion 3211 configured forintravascular placement and including an angioplasty device 3234 and adistal tip 3235, and an elongate shaft 3213 coupled between proximal endportion 3212 and distal end portion 3211. In the illustrated embodiment,shaft 3213 includes an outer shell 3265 that includes a conductiveportion functioning as a pacing electrode 3232A. Pacing electrode 3232Ais electrically connected to a connector 3216A at proximal end portion3212. In one embodiment, outer shell 3265 includes a flexible metaltube. In one embodiment, pacing electrode 3232A includes approximatelythe entire outer shell 3265, or a substantial portion of outer shell3265. In the illustrated embodiment, angioplasty catheter 3210 alsoincludes an elongate conductive inner portion 3266 extending throughapproximately the enough length of angioplasty catheter 3310. Innerportion 3266 includes an exposed conductive distal end functioning asanother pacing electrode 3232B. Pacing electrode 3232B is electricallyconnected to a connector 3216B at proximal end portion 3212. In oneembodiment, inner portion 3266 is a flexible metal wire. In anotherembodiment, inner portion 3266 is a flexible metal tube. In oneembodiment, angioplasty device 3234 includes a balloon. Inner portion3266 is a flexible metal tube with a lumen that allows for inflation anddeflation of balloon 3234. When inflated, balloon 3234 functions as ananchor to stabilize the location of pacing electrodes 3232A-B. Forexample, after expanding balloon 3234, electrodes 3232A-B are positionedby sliding sleeve 3260 along shaft 3213.

FIG. 33 is an illustration of an embodiment of an angioplasty catheter3310, which is another embodiment of angioplasty device 3210.Angioplasty catheter 3310 is a PTVI device that includes a proximal endportion 3312, a distal end portion 3311 configured for intravascularplacement and including an angioplasty device 3234 and a distal tip3335, and an elongate shaft 3313 coupled between proximal end portion3312 and distal end portion 3311. Angioplasty catheter 3310 differs fromangioplasty catheter 3210 in that shaft 3313 includes an outer shell3365 that is coated with an insulation material to leave one or moreexposed areas functioning as one or more pacing electrodes. In theillustrated embodiment, outer shell 3365 is coated with the insulationmaterial to leave an exposed area functioning as a pacing electrode3332A, which is electrically connected to connector 3216A at proximalend portion 3312.

In various embodiments, angioplasty catheters 2910, 3110, 3210, and 3310each allow one or more pacing electrodes to be positioned by movingalong and within a blood vessel after an expandable angioplasty devicesuch as a balloon is expanded to function as an anchor. In oneapplication, the one or more pacing electrodes are placed according tothe pacing energy required, such as by locating the pacing site(s)associated with approximately minimum amplitude or width of the pacingpulses. In various embodiments, angioplasty catheters 2910, 3110, 3210,and 3310 each allow for delivering combined ischemic cardioprotectiontherapy by inflating and deflating a balloon of the catheter and pacingcardioprotection therapy by delivering cardioprotective pacing via oneor more of the pacing electrodes of the catheter.

Example: Pacing Catheter with Stent Electrode

FIGS. 34-37 illustrate various examples of pacing electrode constructedas a stent or incorporated onto a stent. The stent is connected to aPTVI catheter. After being used for delivering pacing pulses during arevascularization procedure, the stent is disconnected from the PTVIcatheter to stay in the patient, or removed from the patient with thePTVI catheter. In various embodiments, the pacing pulses are deliveredwhen the stent is in its expanded state in a blood vessel for a stableelectrical contact between the pacing electrode and the vascular wall ofthe blood vessel.

FIG. 34 is an illustration of an embodiment of a pacing catheter 3410.Pacing catheter 3410 is a PTVI device assembly including a stentcatheter 3410A, a sheath 3410C, and a guide wire 3410D.

Stent catheter 3410A includes a catheter proximal end portion 3412A, acatheter distal end portion 3411A configured for intravascular placementand including a stent 3468, an elongate catheter shaft 3413A coupledbetween proximal end portion 3412A and distal end portion 3411A, and acatheter lumen 3430A extending within shaft 3413A between proximal endportion 3412A and distal end portion 3411A. Stent 3468 includes a pacingelectrode 3432A. A conductor 3433A electrically connects pacingelectrode 3432A to a connector 3416A at proximal end portion 3412A. Inthe illustrated embodiment, another pacing electrode 3432B isincorporated onto shaft 3413A. Another conductor 3433B electricallyconnects pacing electrode 3432B to a connector 3416B at proximal endportion 3412A.

Sheath 3410C includes a sheath proximal end portion 3412C, a sheathdistal end portion 3411C configured for intravascular placement, anelongate sheath shaft 3413C coupled between proximal end portion 3412Cand distal end portion 3411C, and a sheath lumen 3430C extending withinshaft 3413C between proximal end portion 3412C and distal end portion3411C. Lumen 3430C has a diameter accommodating a portion of stentcatheter 3410A, including shaft 3413A and stent 3468 in its restrainedstate. Lumen 3430C has a proximal opening 3443C at distal end portion3412C and a distal opening 3442C at distal end portion 3411C. In oneembodiment, sheath 3410C is a guide catheter used in a revascularizationprocedure. In the illustrated embodiment, a pacing electrode 3432C isincorporated onto distal end portion 3411C. A conductor 3433Celectrically connects pacing electrode 3432C to a connector 3416C atproximal end portion 3412C.

Guide wire 3410D includes a guide wire proximal end portion 3412D, aguide wire distal end portion 3411D including a guide wire distal tip3435D, and an elongate guide wire shaft 3413D coupled between proximalend portion 3412D and distal end portion 3411D. In the illustratedembodiment, a pacing electrode 3432D is incorporated onto distal tip3435D. A conductor 3433D electrically connects pacing electrode 3432D toa connector 3416D at proximal end portion 3412D.

In one embodiment, stent catheter 3410A is a stent delivery catheter,and stent 3468 is detachably connected to shaft 3413A to be permanentlyimplanted in a blood vessel after the pacing pulses are delivered duringthe revascularization procedure. In another embodiment, stent catheter3410A is dedicated for pacing during the revascularization procedure,and stent 3468 is non-detachably connected to shaft 3413A to be removedfrom the blood vessel after the pacing therapy is completed.

In one embodiment, stent 3468 includes metal mesh functioning as pacingelectrode 3432A. In another embodiment, pacing electrode 3432A is anelectrode attached onto the mesh of stent 3468.

In various embodiments, stent 3468 is expandable and contractible bypushing and pulling sheath 3410C and/or stent catheter 3410A. Stent 3468exits from lumen 3430C through distal opening 3442C by pulling sheath3410C toward the proximal direction (away from the patient) and/orpushing stent catheter 3410A toward the distal direction (toward thepatient). In one embodiment, stent 3468 is self-expandable upon exitingfrom sheath 3410C through distal opening 3442C. Stent 3468 is alsoretractable into lumen 3430C through distal opening 3442C by pushingsheath 3410C toward the distal direction (toward the patient) and/orpulling stent catheter 3410A toward the proximal direction (away fromthe patient).

In various embodiments, pacing catheter 3410 includes pacing electrode3432A and one or more of pacing electrodes 3432B-D. In one embodiment,as illustrated in FIGS. 35 and 36 below, stent 3468 includes two pacingelectrodes, and pacing electrodes 3432B-D are optional.

FIG. 35 is an illustration of an embodiment of a distal end portion3511A of a stent catheter 3510A, which is another embodiment of stentcatheter 3410A. Distal end portion 3511A includes a stent 3568. Pacingelectrodes 3532A-B are each affixed onto the mesh of stent 3568 andconnected to one of conductors 3533A-B extending through a cathetershaft 3513A.

FIG. 36 is illustration of an embodiment of a distal end portion 3611Aof a stent catheter 3610A, which is another embodiment of stent catheter3410A. Distal end portion 3611A includes a stent 3668. Pacing electrodes3632A-B each include a portion of the mesh of stent 3668 and connectedto one of conductors 3633A-B extending through a catheter shaft 3613A.The two mesh portions forming pacing electrodes 3632A-B are electricallyinsulated from each other.

FIG. 37 is an illustration of an embodiment of a distal end portion3711A of a stent catheter 3710A, which is another embodiment of stentcatheter 3410A. Distal end portion 3711A includes a stent 3768detachably connected to a catheter shaft 3713A through a connector 3769.Stent 3768 is capable of functioning as a pacing electrode 3732A whenbeing connected to shaft 3713A through connector 3769, which alsoprovides electrical connection between pacing electrode 3732A and aconductor 3733A extending through shaft 3713A. Connector 3769 isdissolvable by electrolysis when exposed to the blood. In oneembodiment, connector 3769 is dissolved by applying an electricalcurrent through it while being exposed to the blood. This allows stent3768 to be disconnected from shaft 3713A and stay in the blood vesselafter the pacing pulses are delivered during the revascularizationprocedure.

It is to be understood that the above detailed description, includingthe various examples of PTVI devices and external pacemakers, isintended to be illustrative, and not restrictive. In general,cardioprotective pacing is applied to prevent or reduce cardiac injuryassociated with ischemia by using one or more pacing electrodesincorporated onto any intravascular device and a pacemaker that iscapable of delivering pacing pulses by executing a cardioprotectivepacing protocol. Other embodiments will be apparent to those of skill inthe art upon reading and understanding the above description. The scopeof the invention should, therefore, be determined with reference to theappended claims, along with the full scope of equivalents to which suchclaims are entitled.

What is claimed is:
 1. A percutaneous transluminal vascular intervention(PTVI) device assembly for use during revascularization of a bloodvessel, the PTVI device assembly comprising: a plurality of pacing leadseach including a pacing lead distal end portion and one or more pacingelectrodes incorporated onto the pacing lead distal end portion; acatheter including: a catheter proximal end portion; a catheter distalend portion configured to be placed in the blood vessel and including acatheter distal tip; an elongate catheter shaft coupled between thecatheter proximal end portion and the catheter distal end portion; oneor more entry ports at the catheter proximal end portion; a plurality ofexit ports including at least one exit port at the catheter distal tip;and a further pacing electrode at the catheter distal tip, the catheterconfigured to allow the pacing lead distal end portion of each pacinglead of the plurality of pacing leads to enter an entry port of the oneor more entry ports and exit from an exit port of the plurality of exitports; and a pacemaker configured to be connected to the pacing leaddistal end portions of the plurality of pacing leads, the pacemakerincluding: a pacing output circuit configured to deliver pacing pulsesthrough the one or more pacing electrodes and the further pacingelectrode; and a control circuit coupled to the pacing output circuitand configured to execute a cardioprotective pacing protocol specifyingone or more cardiac protection pacing sequences each includingalternating pacing and non-pacing periods, the pacing periods eachhaving a pacing duration during which a plurality of the pacing pulsesis timed to be delivered according to a stress augmentation pacing modeto augment myocardial mechanical stress to a level effectingcardioprotection against myocardial injury, the non-pacing periods eachhaving a non-pacing duration during which none of the pacing pulses istimed to be delivered.
 2. The PTVI device assembly of claim 1, whereinthe pacing leads each comprise: a pacing lead proximal end portion; andan elongate pacing lead shaft coupled between the pacing lead proximalend portion and the pacing lead distal end portion.
 3. The PTVI deviceassembly of claim 1, wherein the catheter shaft comprises an exit portof the plurality of exit ports.
 4. The PTVI device assembly of claim 1,wherein the catheter comprises a plurality of guiding channels eachincluding a lumen extending within a portion of the catheter shaft andincluding a proximal opening at an entry port of the one or more entryports and a distal opening at an exit port of the plurality of exitports, the guiding channels each configured to allow the pacing leaddistal end portion of the each pacing lead of the plurality of pacingleads to pass through.
 5. The PTVI device assembly of claim 4, whereinthe exit ports are arranged to allow the distal end portions of thepacing leads to enter the blood vessel and one or more blood vesselsbranching from the blood vessel.
 6. The PTVI device assembly of claim 1,wherein the plurality of pacing leads comprises two pacing leads.
 7. ThePTVI device assembly of claim 1, wherein the plurality of pacing leadscomprises more than two pacing leads.
 8. The PTVI device assembly ofclaim 1, wherein the pacing leads each comprise a plurality of pacingelectrodes incorporated onto the pacing lead distal end portion.
 9. ThePTVI device assembly of claim 1, wherein the pacemaker furthercomprises: a chassis housing the pacing output circuit and the controlcircuit; and a user interface incorporated onto the chassis, the userinterface configured to allow control of the delivery of the pacingpulses by a user.
 10. The PTVI device assembly of claim 1, wherein thecontrol circuit is configured to apply rapid, asynchronous pacing duringeach of the pacing periods.
 11. The PTVI device assembly of claim 1,wherein the control circuit is configured to cause delivery of thepacing pulses at a rate substantially higher than an intrinsic heartrate during each of the pacing periods.
 12. The PTVI device assembly ofclaim 11, wherein the stress augmentation pacing mode is a bradycardiapacing mode.
 13. The PTVI device assembly of claim 11, wherein thestress augmentation pacing mode is an asynchronous pacing mode.
 14. ThePTVI device assembly of claim 1, wherein the one or more cardiacprotection pacing sequences each include approximately 1 to 4 cycles ofthe alternating pacing and non-pacing periods.
 15. The PTVI deviceassembly of claim 14, wherein the pacing periods are each in a range ofapproximately 30 seconds to 20 minutes, and the non-pacing periods areeach in a range of approximately 30 seconds to 20 minutes.
 16. The PTVIdevice assembly of claim 15, wherein the one or more cardiac protectionpacing sequences each include 3 cycles of the alternating pacing andnon-pacing periods, the pacing periods are each approximately 5 minutes,and the non-pacing periods are each approximately 5 minutes.
 17. ThePTVI device assembly of claim 14, wherein the pacing periods are each ina range of approximately 10 seconds to one minute, and the non-pacingperiods are each in a range of approximately 10 seconds to one minute.18. The PTVI device assembly of claim 17, wherein the one or morecardiac protection pacing sequences each include approximately 2 to 4cycles of the alternating pacing and non-pacing periods, the pacingperiods are each approximately 30 seconds, and the non-pacing periodsare each approximately 30 seconds.
 19. The PTVI device assembly of claim1, further comprising a pacing protocol module configured to bedetachably connected to the pacemaker, the pacing protocol modulestoring the cardioprotective pacing protocol.
 20. The PTVI deviceassembly of claim 19, wherein the cardioprotective pacing protocolspecifies the stress augmentation pacing mode with pacing parametersincluding an atrioventricular delay selected to augment the myocardialmechanical stress to the level effecting cardioprotection againstmyocardial injury.